BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2910465 · Received December 3, 2012

    Report

    Report Number
    9610816-2012-00488
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 14, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT HE WAS GETTING "SPEAKER MALFUNCTION" MESSAGE ON HIS MP70 MONITOR. THERE IS NOT ENOUGH INFO TO DETERMINE IF THERE WAS ANY SOUND. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS GETTING "SPEAKER MALFUNCTION" MESSAGE ON HIS MP70 MONITOR. THERE IS NOT ENOUGH INFO TO DETERMINE IF THERE WAS ANY SOUND. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1